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Sponsors and Collaborators: |
Benaroya Research Institute Sanofi-Aventis |
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Information provided by: | Benaroya Research Institute |
ClinicalTrials.gov Identifier: | NCT00761241 |
This study is being conducted to find out what effects (good and bad) that a combination of treatment with chemotherapy, radiation therapy and surgery has on you and your pancreatic cancer. The chemotherapy drugs to be used: Gemcitabine, Docetaxel, Oxaliplatin, 5-FU and alpha-interferon. The goal is to decrease the size of the tumor, so that removal by surgery can be performed. Current treatments for this stage of pancreas cancer offer less than ideal results, with little opportunity for treatment with curative intent.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: Gemcitabine, Docetaxel, 5FU, Oxaliplatin Biological: Alpha-interferon Radiation: Abdominal/pelvic radiation therapy Procedure: Pancreaticoduodenectomy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Protocol in Borderline Resectable Pancreatic Cancer Using Gemcitabine/Docetaxel Chemotherapy and An Oxaliplatin-Based Chemoradiation. |
Estimated Enrollment: | 40 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Subjects must have biopsy proven adenocarcinoma of the pancreas which is bidimensionally measurable on CT. Cancer must be considered locally advanced (not able to be treated surgically). Subjects must not have received prior treatment for pancreatic cancer. Subjects must not have received prior radiation therapy to the abdomen or pelvis (for any reason). Subjects cannot be receiving immunosuppressive therapy (e.g. prednisone, methotrexate). Eligible subjects will receive initial chemotherapy regimen to include eight cycles of Gemcitabine and Docetaxel. All subjects will be re-evaluated for surgery - if tumor has shrunk enough, subject will undergo surgery, followed by additional chemotherapy of Oxaliplatin, 5FU and Alpha-interferon and radiation therapy; once subject has recovered from side effects of the chemo/radiation therapy, they will receive a final chemotherapy regimen of four cycles of Gemcitabine and docetaxel. Subjects who are not surgical candidates after eight cycles of chemotherapy will undergo an additional four cycles of Gemcitabine and docetaxel followed by reassessment for surgery. If they are a surgical candidate, they will undergo surgery followed by chemo/radiation therapy regimen. If they are not a surgical candidate, they will undergo the chemo/radiation therapy regimen.
Subjects may be removed from the study treatment for the following reasons:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Leila Canlas | 206-625-7373 ext 67960 |
United States, Washington | |
Virginia Mason Medical Center | Recruiting |
Seattle, Washington, United States, 98101 |
Principal Investigator: | Vincent Picozzi, MD | Virginia Mason Medical Center |
Responsible Party: | Virginia Mason Medical Center ( Vincent Picozzi, MD/Principal Investigator ) |
Study ID Numbers: | IRB07124, IST14087 |
Study First Received: | September 25, 2008 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00761241 |
Health Authority: | United States: Institutional Review Board |
pancreas cancer combined modality therapy |
Interferon-alpha Digestive System Neoplasms Pancreatic Neoplasms Interferons Endocrine System Diseases Pancrelipase Docetaxel Oxaliplatin |
Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Interferon Alfa-2a Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |